TUESDAY, Dec. 28, 2021 (HealthDay News) – E-cigarettes flavored for kids are still widely available online and in stores, despite a federal judge ruling that should have pulled products off store shelves in early September, a new report shows.
The judge’s verdict came after nearly two years of action by the US Food and Drug Administration.
Citing risks to vulnerable children, the FDA first announced in January 2020 that “companies that do not stop producing, distributing and selling unauthorized e-cigarettes with flavored cartridges [other than tobacco or menthol] within 30 days the risk of the FDA’s implementation. “
That was then, this is now, critics say.
Today more than 100 flavored vaping tempting-flavored products such as Gummy Bear, Funnel Cake, Fruit Punch, Berry Crunch Cereal and Blueberry Lemonade continue to be sold through five leading online e-cigarette retailers, a Campaign for Children Without Tobacco showed.
Flavored vapes were also widely available at stores and gas stations located in eight cities across the country, report added.
“Flavored e-cigarettes of exactly the kind that young people use are widely available both online and in retail outlets,” said Matthew Myers, president of the Campaign for Tobacco-Free Children.
“Flavors attract them. Nicotine depends on them,” Myers continued. “Without taste, far fewer children would be attracted to these products – 85% of children who use an e-cigarette use one with flavor.”
A federal court has set a September 9 deadline for e-cigarette manufacturers to either obtain approval from the U.S. Food and Drug Administration for their products or face market recalls.
Unauthorized e-cigarette products remain on the market for months after that deadline, even though they are subject to FDA measures, the report said.
Estimates in stores conducted in eight cities showed the following:
- Juul was sold in all cities, and brands like Vuse, NJOY and blu were available in most.
- Flavored e-liquids are found in most cities, in flavors such as Green Apple, Cola, Peachy Rings, Tropical Fruit, Strawberry Macaroon and Island Orange.
- Disposable e-cigarettes were available in every city in flavors such as Coconut and Pineapple Smoothie, Strawberry Ice Cream, Teddy Bear, Mango Slushee and Blue Razz Lemonade.
The cities included in the study were Denver; Detroit; Los Angeles; Portland, Maine; Portland, Ore .; Seattle; Tempe, Arizona; and Washington, DC.
The report helps explain why e-cigarette sales continue to skyrocket in the United States, Myers said.
Sales of disposable e-cigarettes increased by almost 250% between February 2020 and September 2021, rising from 2.8 million units to 9.6 million units, according to recent sales monitoring was reported by the CDC Foundation.
Four of the five disposable e-cigarettes sold come in a variety of flavors other than tobacco, mint and menthol, the CDC Foundation said.
Total e-cigarette sales grew by more than 60% over the same period (from about 15 million to 24 million units), the CDC Foundation reports. This includes sales of e-cigarettes without tobacco, which increased by 86%.
Approximately 1 in 5 high school seniors has used an e-cigarette in the past month, according to federal research cited by Myers.
The FDA has yet to act
“That’s five times more kids who use e-cigarettes than they use cigarettes,” Myers noted.
The FDA says it has acted on more than 98% of e-cigarette applications received and issued rejection orders for more than a million flavored vaping products, the report said.
However, the agency has delayed reviewing e-cigarette maker applications with the largest market shares, such as Juul, Vuse Alto, NJOY, blu, Smok and Suorin, the report said.
Until decisions are made on these applications, the FDA has indicated that the products can still be sold. Attempts to reach a comment agency were unsuccessful.
“Clearly, the FDA really needs to act quickly and address the remaining requirements that need to go,” said Erika Sward, assistant vice president of national advocacy for the American Lung Association. “They’ve claimed to go through millions of apps, but when you leave the products with the largest market share in the market, it’s actually just a drop in the bucket.”
Sward and Myers suspect the FDA is cautious and meticulous in considering large manufacturers ’requests to have its final decisions upheld in court.
The agency is already facing more than 45 lawsuits from companies whose products have been rejected, Myers said.
“These apps may be more complete and content than many smaller company products,” Sward said of major e-cigarette brands. “I’d also assume the FDA is trying to put all the dots on I and over T, because while some smaller manufacturers are suing the FDA for refusing marketing, they’re trying to avoid big lawsuits by big companies.”
The FDA is also struggling with a big hole that some companies are using to continue selling flavored products.
Puff Bar and other manufacturers have started selling e-cigarettes that contain synthetic nicotine. The companies claim that this “tobacco-free nicotine” does not fall under the jurisdiction of the FDA’s Tobacco Control Center.
The FDA issued a warning letter against Puff Bar in July 2020, ordering the company to remove its flavored disposable e-cigarettes from the market because they did not have the necessary authorization.
In response, Puff Bar re-launched a new synthetic nicotine formula this February that it claims does not fall under current FDA rules for vaping products.
Synthetic nicotine new trick
The agency said in the online FAQ that it is possible that synthetic nicotine “would not be regulated by the FDA as a tobacco product”, adding that it would decide on a case-by-case basis.
However, Sward and Myers believe the FDA still has the authority to approve these products. Even if it is not derived from tobacco, synthetic nicotine remains a new drug that should be regulated, they argue.
“It’s clear to us that even if the Tobacco Products Center doesn’t have jurisdiction over those products, the Drug Assessment Center can confirm jurisdiction over those products as unauthorized drugs – but it’s not,” Myers said.
The way companies advertise their synthetic nicotine products seems to justify treating the substance as a drug, said Dr. Linda Richter, vice president of prevention and analysis for prevention for the End-of-Addiction Partnership.
“Many companies that sell these synthetic nicotine products say, ‘Hey, it’s cleaner than the nicotine that comes from tobacco, it has these great ingredients and it won’t hurt you. They promote it in some way through health benefits, which puts it under FDA regulatory regulation.’ drugs, ”Richter said.
It would be even better for Congress to intervene in this regard synthetic nicotinesaid Myers.
“The best possible solution would be for Congress to clarify the definition of a tobacco product to specifically include those products,” Myers said. “Otherwise, the FDA will play whack-a-mole from now on to the kingdom.”
Overall, the FDA has been timid in the face of constant opposition from the vaping industry and must step up its efforts, Myers and Sward said.
“They had more than three months after the deadline from a federal judge to deal with these products and it’s very discouraging that they haven’t so far,” Sward said.
“The clear conclusion is that as long as flavored products are for sale, children will get them. The only way to protect children from flavored products is to make their sale illegal,” she concluded.
However, the FDA could simply be overpowered and overpowered, Richter said.
“I just don’t know he has the staff and the resources to keep up with this extremely well-funded industry, especially given that there are a lot of people in government who don’t think regulations should be as strong as they are,” Richter said.
“Even with something like cigarettes that obviously have no redemption value, you still have very well-funded tobacco lobbyists who continue to restrict cigarette regulations because of their economic interest,” she added.
“Then you turn to a product like vaping that’s presented as something healthier, so you have a lot of people in Congress and regulators who say, hey, be careful how much we limit them because it could deter people from quitting. It’s a murky landscape that it allows a lot to go on, ”Richter concluded.
The Addiction End Partnership has more on that new nicotine products for children.
SOURCES: Matthew Myers, President, Tobacco Free Campaign; Erika Sward, Assistant Vice President, National Advocacy, American Lung Association; Linda Richter, Ph.D., Vice President, Prevention Research and Analysis, Addiction End Partnership; E-cigarette market update, Campaign for Children Without Tobacco, December 17, 2021